A Randomised Clinical Trial: Conventional Ligation vs Figure of 8
This study is currently recruiting participants.
Verified January 2013 by University of Birmingham
Sponsor:
Rachel Little
Information provided by (Responsible Party):
Rachel Little, University of Birmingham
ClinicalTrials.gov Identifier:
NCT01771692
First received: January 16, 2013
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a lot of research into the factors that can affect the speed of alignment of teeth but there has been very little research on how different techniques of wire attachment to the brace (ligation) can affect this.
The randomised clinical trial of 100 patients aims to compare the speed of alignment of the lower (mandibular) front teeth (incisors) using two different techniques over a period of 12 weeks. Both techniques use the conventional small elastic rings (modules) that are placed over each metal square (bracket) but they will be tied in a different configuration for each group. We will also observe any differences in the distances between the corresponding teeth either side of the lower jaw for each group and the bracket failure rates.
| Condition | Intervention |
|---|---|
|
Malocclusion |
Other: Extraction Other: Non extraction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study Into the Effects of Different Ligation Techniques on Orthodontic Mandibular Incisor Alignment |
Resource links provided by NLM:
Further study details as provided by University of Birmingham:
Primary Outcome Measures:
- Little's irregularity index. [ Time Frame: up to12 weeks ] [ Designated as safety issue: No ]Mandibular incisor irregularity index reduction using Little's irregularity index.
Secondary Outcome Measures:
- Intercanine width. [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]Changes in intercanine widths between the two groups.
Other Outcome Measures:
- Intermolar width. [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]Changes in intermolar widths between the two groups.
- Bracket failure rate. [ Time Frame: 0,6,12 weeks ] [ Designated as safety issue: No ]Compare orthodontic bracket failure rates between the two groups.
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional ligation
Modules ligated in a conventional manner (figure of 0)
|
Other: Extraction
Extraction of teeth in the lower arch as part of the orthodontic treatment plan
Other: Non extraction
Non extraction in the lower arch as part of the orthodontic treatment plan
|
|
Active Comparator: Figure of 8 ligation
Modules ligated in a figure of 8 configuration
|
Other: Extraction
Extraction of teeth in the lower arch as part of the orthodontic treatment plan
Other: Non extraction
Non extraction in the lower arch as part of the orthodontic treatment plan
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients at Burton Hospital
- 12-15 years of age at the start of treatment
- No medical contraindications
- Permanent dentition
- Mandibular incisor irregularity of 5-10mm (using Little's irregularity index)
- No other therapeutic intervention e.g. elastics, coils
- Informed consent gained
Exclusion Criteria:
- Presence of a craniofacial syndrome
- Patients already participating in a research study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771692
Contacts
| Contact: Rachel A Little, BDS MFDS | 00441283566333 | ralittle8@gmail.com |
| Contact: David J Spary, BDS LDS FDS DOrth FDS Orth | 00441283566333 | burtonortho@yahoo.com |
Locations
| United Kingdom | |
| Queen's Hospital, Burton Hospitals NHS Foundation Trust | Recruiting |
| Burton upon Trent, Staffordshire, United Kingdom, DE13 0RB | |
| Contact: Rachel A Little, BDS MFDS 00441283566333 ralittle8@gmail.com | |
| Contact: David J Spary, BDS LDS FDS DOrth FDS Orth 00441283566333 burtonortho@yahoo.com | |
| Principal Investigator: Rachel A Little, BDS MFDS | |
| Sub-Investigator: David J Spary, BDS LDS FDS DOrth FDS Orth | |
Sponsors and Collaborators
Rachel Little
Investigators
| Study Director: | David J Spary, BDS LDS FDS DOrth FDS Orth | Burton Hospitals Foundation Trust |
More Information
No publications provided
| Responsible Party: | Rachel Little, Specialty Registrar in Orthodontics, University of Birmingham |
| ClinicalTrials.gov Identifier: | NCT01771692 History of Changes |
| Other Study ID Numbers: | LIT001 |
| Study First Received: | January 16, 2013 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Birmingham:
|
Orthodontics |
Additional relevant MeSH terms:
|
Malocclusion Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013